Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01088256
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years with
* Persistent moderate or severe pain (\> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
* Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
* One of the two following QST phenotypes at the baseline assessment:
* signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
* without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
* Patients of both gender
* Signed consent form
* Patients with the ability to understand and follow the instructions of the doctor
Exclusion Criteria:
* Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.
Excluded will be also all patients with contradictions for the use of Etoricoxib:
* Hypersensitivity to the active substance or to any of the excipients.
* Active peptic ulceration or active gastrointestinal (GI) bleeding.
* Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
* Pregnancy and lactation
* Severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10).
* Estimated renal creatinine clearance \<30 ml/min.
* Inflammatory bowel disease.
* Congestive heart failure (NYHA II-IV).
* Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
* Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
* Intake of one of the following drugs (current or in the last 3 days)
* selective-serotonin-reuptake-inhibitor
* cetoconazole
* rifampicin
* phenytoin
* carbamazepine
* dexamethasone or other systemic corticoids
* traditional nonsteroidal antiphlogistics
* cyclooxygenase-inhibitors
* immunosuppressives
* TNF-α-inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01088256
Study Brief:
Protocol Section:
NCT01088256